Technical Writer (OPEN for consultancy)

Purpose of the position:

The Technical Writer is responsible for defining and carrying out the activities which are related to the labelling (but not labels), and coordinates the review, the formatting and the publishing of the customer documentation and instructions related to the Biocartis molecular diagnostics platforms. This is currently the Idylla^TM platform. 

In addition the Technical Writer coordinates and facilitates the translation process, including review and approval of translated documentation.

Accountabilities:

• Handle the creation and ongoing maintenance of the Instructions for Use (IFU) of the Idylla^TM platform (all sub-systems) and the tests and assays (paper and digital documents) in multiple languages, for the following:
  • The Operator Manual for the Idylla^TM instrument and console and software;
  • IFU and Assay Instructions of Idylla^TM tests and assays developed by Biocartis as the legal manufacturer;
  • Tools - Lab Integration Guide and Site Preparation Guide;
  • Service Manuals;
  • Other required customer facing documentation and guides upon request.
• Coordinate the input required from design specialists in the development teams; and drive the documentation collaboration, review and approval process;
• Coordinate and facilitate the translation process, including review and approval of translated documentation;
• Perform the necessary lay outing, readability and publishing of the final documents;
• Participate in cross-functional sub projects;
• Participate in the supplier selection process and relationship development with translation or graphic design partners;
• Comply with and continue to monitor specific in country regulations and standards as they apply to Labeling;
• Evolve best practices for labeling designs against required International standards and the creation of templates to facilitate future documentation improvements;
• Understand and comply with company guidelines and regulations;
• Send out customer communications (such as customer letters and software release notes) to a selected customer database;
• Support with gatekeeping (review/approval) of customer-facing documentation/materials;
• On an as needed base, support logistics and promotional content related to Biocartis Event planning.

Profile & Competencies:

• Bachelor in science or related discipline, or equivalent by training and/or experience;
• A minimum of 2 years relevant experience with skills in Technical Writing and Publishing;
• Experience in technical writing, document & content management, and creation of manuals and alike materials;
• Demonstrated competency in coordination and/or project management to keep track of multiple activities and stages of completion;
• Interpersonal skills to take part in a dynamic team environment while taking on multiple projects simultaneously;
• Knowledge of translation processes;
• Fluent in English; any other European language is an added value;
• Administrative/coordination skills;
• Familiarity with lay-outing documents and graphical editing processes;
• Knowledge of business processes & policies (e.g. review processes and budgeting);
• Knowledge of the software used in Technical Writing and Publishing in multiple languages; i.e. Madcap Madpak, Flare and Lingo;
• Knowledge of Microsoft office suite (Outlook, Excel, PowerPoint, Word);
• Knowledge of Adobe Acrobat, Adobe Illustrator, Adobe Photoshop (or other image editing knowledge):
• Preferable to have knowledge of/experience in
  • Idylla products (Platform, Tests and Assays) and basic Idylla technology;
  • Medical Devices or IVD technology/environment;
  • GDPR;
  • IVDR;
  • Validation and ISO regulation/guidelines;
  • Management of working with external partners;
  • Salesforce Marketing Cloud (Email Studio);
  • PowerBI;
  • Microsoft Dynamics.
• Quality Orientation; consistently complies with product/ service quality standards with attention to detail to ensure accurate, high quality documentation output;
• Good team skills - a high level of enthusiasm and motivation, able to build consensus with multiple stakeholders;
• Innovation: Contributes innovative ideas that lead to positive business results; encouraging and adopting new ways of looking at problems, processes and solutions;
• Judgment: Ability to make timely and sound decisions based on thorough consideration of relevant information and the pros and cons of alternatives;
• Thrive in a changing and innovative environment.

Our offering

We offer you a challenging job in an exciting environment, working for top entrepreneurs in the biotech industry. You can be part of a very dynamic, young and growing team in a highly innovative environment. You will have freedom to shape your work and shape your job. Your input is highly appreciated. Of course we offer you a competitive compensation package which includes a Flexible Income Plan. Flexibility is granted via a hybrid work regime.